Future-oriented aseptic Clean by Design according to ASTM E55.

09 juli 2025

Rodesta supports pharmaceutical production with Clean by Design: efficient, safe and sustainable aseptic process design according to international guidelines and ASTM E55.

Function

In the pharmaceutical industry, safety, sterility and reproducibility are essential. Modern aseptic production systems must not only operate reliably, but also be easy to clean and meet increasingly strict sustainability requirements.

The ASTM E55 technical committee develops important guidelines to support this. The core principle is clear: Clean by Design. This means designing systems so that cleaning, sterilization, validation and process safety are integrated from the very beginning.

The ASTM E55 guidance focuses on structural improvements in:

• Aseptic process design: optimal layout and material selection for sterile processes
• Cleaning in Place (CIP) and Sterilization in Place (SIP): validated cleaning and sterilization without disassembly
• Eliminating dead leg areas: no product hold-up or cleaning shadows
• Cleaning validation: reproducible and verifiable cleaning results
• Sustainable resource usage: reduced water, energy and chemical consumption

These principles enable more efficient processes, less downtime and lower operating costs.

Clean by Design as a practical standard

Clean by Design means that process systems are developed from the outset for validated CIP and SIP processes. This prevents costly retrofits and ensures reliable performance from day one.

The benefits are clear:

• Shorter cleaning times: faster return to production
• Lower resource consumption: savings on water, chemicals and energy
• Lower cost per batch: more efficient production without compromising quality
• Increased process reliability: consistent performance with minimal variation
• Reduced contamination risk: by eliminating dead leg areas

Clean by Design has become a standard approach in modern pharmaceutical and biotech production facilities.

International standards

Relevant international standards and guidelines for pharmaceutical production:

• ASTM E55: guidance on aseptic design, cleaning and validation
• ASME BPE: design standards for process components in sterile environments
• ISPE Baseline Guide Volume 5: guidance on commissioning and qualification of pharmaceutical systems
• EU GMP Annex 1: guidelines for aseptic manufacturing and contamination control

Combining these standards results in process designs that are easier to validate and comply with global regulations.​

Sustainable aseptic processes

Clean by Design plays a key role in sustainable pharmaceutical production. Reducing cleaning times and resource consumption not only delivers economic benefits but also lowers the environmental footprint.

Key benefits for your process:

• Reduced water consumption: more efficient cleaning cycles save thousands of liters per batch
• Lower energy consumption: less hot water and steam required
• Reduced chemical usage: lower costs and environmental impact
• Higher uptime: less downtime, more production capacity
• Consistent cleaning results: easier to validate, reducing the risk of batch rejection

This approach prepares your production environment for future regulatory and operational requirements, with fewer risks, lower costs and greater reliability.

Consulting for Clean by Design in your process

Implementing Clean by Design requires technical expertise in aseptic design, cleaning validation and international standards.

We support you with:

• Analysis of your existing process layout: identifying risks and optimization opportunities
• Design of new aseptic systems: fully focused on cleanability, sterility and validation
• Selection of suitable process components: in accordance with ASTM E55, ASME BPE and GMP
• Validation support: practical assistance with cleaning and sterilization validation

Ready for a sustainable aseptic system?

Clean by Design is not a trend, but the new industry standard. By designing processes to be cleanable, sterilizable and validatable from the very start, your system meets today’s and tomorrow’s requirements.

Would you like to learn more about Clean by Design or how to apply ASTM E55 in your process?
Contact us for technical advice, design support or a tailored consultation.